PCT International Application Publication Nos. WO 2008/097561, WO 2009/020565, WO 2010/014141, WO 2010/014220, WO 2010/014254, WO 2010/147612, and WO 2012/162535 describe small molecule protein phosphatase 2A (PP2A) inhibitors and their use for treating a variety of conditions including cancers, neurodegenerative diseases, and diseases characterized by loss of protein function.
One of the PP2A inhibitors described in PCT International Application Publication No. WO 2008/097561, LB-100, has shown antiproliferative activity as a single agent and in combination with other cytotoxic agents against cancer cells in vitro and against tumor xenografts in in vivo animal models. For example, LB-100 was shown to inhibit the growth of glioblastoma multiforme (GBM) xenograft cells (Lu et al., J. Neurosurg. 113:225-233 (2010)), increase the effectiveness of the standard anti-sarcoma chemotherapeutic agent doxorubicin in a rat fibrosarcoma model (Zhang et al., Biomaterials vol. 31(36):9535-43 (2010)), and delay tumor growth when administered with temozolomide (TMZ) in a mouse model of metastatic pheochromocytoma (PHEO) (Martiniova et al., Plos One, vol. 6(2):e14678 (2011)).
To date, the PP2A inhibitors described in PCT International Application Publication Nos. WO 2008/097561, WO 2009/020565, WO 2010/014141, WO 2010/014220, WO 2010/014254, WO 2010/147612, and WO 2012/162535 have not been explored in human clinical trials. However, LB-100 has been approved by the Food and Drug Administration for Phase I study in patients with advanced cancers given alone and then in combination with the widely used anticancer drug docetaxel.
Accordingly, there is a need for pharmaceutical compositions comprising PP2A inhibitors, and LB-100 in particular, which are suitable for administration to human subjects in, for example, clinical trials. Such pharmaceutical compositions should be stable under long term storage conditions and under the conditions of clinical use.